The contentious debate over use of Red dye No. 3 is over. The U.S. Food and Drug Administration announced Wednesday that it can no longer be used in food and ingested drugs.

Advocates of a ban have long cited a pair of studies in rats that showed a link to cancer. For decades, the FDA said that the dye did not pose a risk to humans because of a “rat-specific hormonal mechanism,” adding that the levels of dye humans ingest is much lower than that linked to the risk in the lab animals.

Manufacturers have until Jan. 15, 2027 to remove the dye from food and beverage formulations and until Jan. 18, 2028 to reformulate ingested drugs so they do not use that particular dye. And though some countries still allow use of Red No. 3, as it’s listed in the Federal Food, Drug, and Cosmetic Act, products imported to the U.S. will have to abide by the ban.

The announcement from the regulatory agency described Red No. 3 as a “synthetic food dye that gives foods and drinks a bright, cherry-red color” and noted that dye “is not as widely used in food and drugs when compared to other certified colors.” It’s most often used in products like candy, cakes and cupcakes, cookies, frozen desserts and frosting and icing, as well as some drugs that are ingested.

“Red dye No. 3 is found in at least dozens of candy, food and beverage products, but some of the most popular brands either never used, or have already stopped using, the additive,” per CNN. “Fewer than 10% of products made by the candy company Ferrara, which produces Brach’s candies, for example, contain the additive, as the company began phasing out the use of it in early 2023, a Ferrara spokesperson said via email.”

A spokesperson for Just Born, which makes Peeps, told CNN that the company already stopped using Red No. 3 in its products last year.

History of contention

Red No. 3 was barred from use in cosmetics more than three decades ago, based on fear of cancer risk.

This week’s action is based on a 2022 petition to the FDA from a couple dozen health and food safety advocates. The FDA based its new ruling on the Delaney Clause, a 1960 amendment to the act that bars authorization of a food additive or color additive that has been linked to cancer in animals or people.

Since the coloring is itself a cosmetic change without nutritional value, advocates of banning it said the dye has no actual value but could create risk.

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According to The Associated Press, Jim Jones, FDA deputy commissioner over human foods, noted that “evidence shows cancer in laboratory male rats exposed to high levels” of the dye. “Importantly,” he added, the mechanism that triggers the cancer in the male rats “does not occur in humans.”

Reaction to the change

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“Today’s action by FDA is long overdue, is a small step in the right direction, and hopefully signals a renewed effort by FDA to do its job despite the many barriers the food industry places in its way,” Jerold Mande, adjunct professor of nutrition at the Harvard University T.H. Chan School of Public Health, told CNN.

The Environmental Working Group, which was among the organizations that sought the ban, issued a press release hailing the ruling to ban the dye, calling it a “historic decision” worth celebrating. The group’s president and cofounder, Ken Cook, said that the nation owes its gratitude to those “who took up this fight decades ago on behalf of consumers.”

The new release cites a 2021 study by California’s Office of Environmental Health Hazard Assessment that found synthetic dyes including Red No. 3 are associated with “greater risk” of decreased attention span, focus, memory problems and other behavioral issues in children.

California already removed Red No. 3 and three other chemicals from foods made and sold in the state. The action is to take effect in 2027.

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